Cortexyme Alzheimer’s drug hit with clinical hold

Jan. 28, 2022

Clinical trials for a new Alzheimer's drug developed by San Francisco-based drugmaker Cortexyme have been paused after the U.S. FDA placed a full clinical hold on the company's investigational new drug application.

The drug, atuzaginstat, took a new approach to Alzheimer’s treatment by targeting the P. gingivalis enzyme in the brain as a potential source of disease.

After receiving notice of the hold, Cortexyme announced it would immediately implement a cost reduction program and begin prioritizing other treatments. One of them is gingipain inhibitor called COR588. COR588 is currently in phase 1 SAD/MAD study with results expected between April and June.

Atuzaginstat has had a rocky road up to this point. In February, the FDA placed a partial clinical hold on trials after finding liver-related side effects. In October, disappointing trial results rolled in as results failed to show a significant benefit in patients from the treatment. In November, Cortexyme announced it would present additional information on the observed positive effects of the study, which included a deceleration of cognitive decline in some patients and conduct another trial to determine if the effects were indicative of potential treatment benefits.

Cortexyme also plans to look at using atuzaginstat in other ways going forward. The drug is currently in phase 1/2 of clinical trials for use in Parkinson’s disease. There is also potential for other non-Alzheimer’s uses, the company said.